Hyperlipidemias
Conditions
Brief summary
phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers
Interventions
DRUGCKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
DRUGD090, D337
D090 and D337 co-administration(Other Name: Reference drug)
Sponsors
Seoul National University Bundang Hospital
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between 19 aged and 45 aged in healthy male adult 2. Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations. 3. Not abnormal or not clinically significant lab values. 4. Subjects who signed informed consent form with good understandings after explanations by investigators.
Exclusion criteria
1. No history or presence of clinically significant diseases. 2. Subjects showing adverse reaction to investigational product 3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. 4. History of myopathy 5. unable to stop drinking and smoking during clinical trials 6. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days 7. History of drug abuse 8. Disagree to contraception 9. Subjects who are in any conditions impossible participating in the clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0~72hours | To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1\) Atorvastatin, unconjugated ezetimibe(Cmax) |
| AUCt | 0~72hours | To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1\) Atorvastatin, unconjugated ezetimibe(AUCt) |
Countries
South Korea
Outcome results
None listed